Oct 01,2024

Eversense 365 Launches in the US: One Year. One CGM.

Ascensia Diabetes Care has launched the Eversense® 365 continuous glucose monitoring (CGM) system, the world’s first One Year CGM, designed to minimize device frustrations for individuals with diabetes. Cleared by the FDA for adults with type 1 and type 2 diabetes, the Eversense 365 allows users to monitor their glucose levels accurately for a full year with only one sensor replacement, reducing the hassle of frequent CGM interruptions common with traditional devices. Users can pay as little as $199 out of pocket for this year-long service, making it accessible for many. The device aims to enhance the quality of life for users by providing reliable alerts and reducing diabetes-related stress, enabling them to focus on their well-being rather than their monitoring technology. Eversense ambassador Troy Ita emphasized how this innovation significantly lessens the burden of managing diabetes, allowing individuals to prioritize family and other important aspects of life.

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Aug 14,2024

Empowering Hospitalized Patients With Diabetes: Implementation of a Hospital-wide CGM Policy With EHR-Integrated Validation for Dosing Insulin

A study at Stanford Health Care assessed the feasibility and acceptance of a hospital-wide continuous glucose monitoring (CGM) policy integrated with electronic health records (EHR) for insulin dosing. From November 2022 to August 2023, 135 patients used the protocol, which included personal CGMs like Dexcom G6 and FreeStyle Libre 2. Results showed that 87.8% of CGM validation attempts met accuracy criteria, and 80% of nurses preferred CGM over traditional fingerstick monitoring. Patient feedback was also positive, indicating effective interactions with nursing staff. The study concluded that the CGM policy is feasible and well-received, suggesting potential for broader implementation.

CLINICAL STUDY

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Sep 23,2024

Early Dysglycemia Is Detectable Using Continuous Glucose Monitoring in Very Young Children at Risk of Type 1 Diabetes

A study from the Australian ENDIA project investigated the use of continuous glucose monitoring (CGM) in young children at risk for type 1 diabetes (T1D). Between January 2021 and June 2023, researchers monitored 31 children with multiple islet autoimmunity (PM Ab+) and 24 control children, ages 4-5. Results showed that PM Ab+ children had higher glucose variability and spent more time with elevated glucose levels compared to controls. CGM was feasible and well-tolerated, revealing early signs of dysglycemia in young children at risk for T1D, consistent with findings in older age groups.

CLINICAL STUDY

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Aug 06,2024

Closed-Loop Insulin Therapy for People With Type 2 Diabetes Treated With an Insulin Pump: A 12-Week Multicenter, Open-Label Randomized, Controlled, Crossover Trial

A study found that closed-loop therapy (combining continuous glucose monitoring with automated insulin delivery) significantly improved glycemic control in people with type 2 diabetes compared to continuous subcutaneous insulin infusion (CSII) plus CGM. Time in range (TIR) increased from 61% to 76%, and other indicators like glucose variability and insulin doses also showed improvement. Sleep fragmentation improved during closed-loop treatment. The study concludes that closed-loop therapy offers better glycemic control than CSII + CGM for this population.

CLINICAL STUDY

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Sep 16,2024

Continuous Glucose Monitoring Market Size Projected to Reach USD 8.82 Billion by 2032

The global Continuous Glucose Monitoring (CGM) market is projected to grow from USD 4.62 billion in 2023 to USD 8.82 billion by 2032, at a CAGR of 7.80%. This growth is driven by the rising prevalence of prediabetes, largely influenced by obesity and unhealthy lifestyles. Prediabetes, if untreated, can lead to type 2 diabetes and cardiovascular diseases, increasing the demand for CGM devices. Additionally, the growing elderly population, particularly vulnerable to diabetes, is expected to further boost market expansion. Key players in the market include Abbott, Dexcom, Medtronic, and Senseonics.

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Sep 16,2024

Brand New Free To use Type 1 Diabetes in Schools Training Platform Launched Today!

DigiBete has launched a new Diabetes in Schools Training Platform to help teachers and school staff in primary and secondary schools better understand and support students with Type 1 diabetes. The platform, co-designed with healthcare professionals, young people, teachers, and parents, offers comprehensive training on key topics such as managing Type 1 diabetes, diabetes technology like insulin pumps and glucose monitors, and the importance of mobile phone accessibility for students. This initiative, in collaboration with Leeds Children’s Hospital and several diabetes organizations, aims to improve both the physical and emotional well-being of young students with diabetes.

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Sep 09,2024

Sustained 3-Year Improvement of Glucose Control With Hybrid Closed Loop in Children With Type 1 Diabetes While Going Through Puberty

The study aims to evaluate the impact of prolonged hybrid closed loop (HCL) use in children with type 1 diabetes (T1D) on glucose control and BMI throughout pubertal progression. The researchers used a prospective multicenter extension study following the Free-Life Kid AP (FLKAP) HCL trial. The 9-month previously reported FLKAP trial included 119 prepubertal children (aged 6–12 years). During the extension study, participants could continue to use HCL for 30 months (M9 to M39). One hundred seventeen children completed the extension study, with mean age 10.1 years (minimum to maximum, 6.8–14.0) at the beginning. Improvement of HbA1c obtained in the FLKAP trial was significantly sustained during extension and did not differ between children who entered puberty at M24 and patients who remained prepubertal. The results showed that prolonged use of HCL can safely and effectively mitigate impairment of glucose control usually associated with pubertal progression without impact on BMI in children with T1D.

CLINICAL STUDY

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Aug 26,2024 TOP STORY

Stelo by Dexcom, the First Over-the-Counter Glucose Biosensor in the U.S., Is Now Available

 DexCom announced that Stelo, the first over-the-counter glucose biosensor in the U.S., is available for purchase without a prescription at Stelo.com. Stelo is a small biosensor(15-day wear time) worn on the back of the upper arm that leverages Dexcom’s  glucose sensing technology. It is specifically designed to provide the 125 million Americans with Type 2 diabetes not using insulin and those with prediabetes with powerful, personalized glucose insights sent directly to a smartphone, revealing how food, exercise and sleep can affect glucose. Dexcom offers two payment models for the users: Pay-as-you-go ($99 for a single pack of two sensors total wear time up to 30 days); and Monthly subscription (Pay $89 per month for an ongoing subscription, with two sensors (total wear time up to 30 days).

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Aug 26,2024

FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes

the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).

REGULATORY FDA

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Sep 04,2024 TOP STORY

Beta Bionics Announces Partnership with Abbott to Integrate the iLet Bionic Pancreas with the FreeStyle Libre 3 Plus iCGM

Beta Bionics announced they are working to integrate Abbott’s glucose sensing technology with the iLet Bionic Pancreas automated insulin delivery system. The iLet will soon connect to Abbott’s FreeStyle Libre 3 Plus continuous glucose sensor, where readings every minute will help the iLet calculate insulin doses. The iLet Bionic Pancreas will be the first AID integration of FreeStyle Libre 3 Plus available in the United States. The integration will launch in Q4 2024 and will offer people a new way to manage their type 1 diabetes that will fit seamlessly into their lives. 

COLLABORATION PARTNERSHIP

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